NCT01994668已完成1 期
A Phase 1, Randomized Single-blind (Subject-blind), Placebo Controlled Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of 2-mg lorazepam intravenous administration in healthy Japanese adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male and/or female subjects of non-childbearing potential.
- •Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.
排除标准
- •History of sensitivity to lorazepam or other benzodiazepines.
- •Evidence or history of acute narrow-angle glaucoma or sleep apnea syndrome.
- •Significant psychiatric disorder, recurrent episodes of severe depression, or subjects with serious suicidal risk.
研究组 & 干预措施
Lorazepam
Experimental
干预措施: Lorazepam (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs).
时间窗: Day 1 to Day 4
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Day 1)
- Area under the Concentration-Time Curve (AUC)(Day1 to Day 4)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in JapanStatus EpilepticusNCT02239380Pfizer26
已完成
1 期
A Study of NKTR-358 (LY3471851) in Healthy ParticipantsHealthyNCT04380324Nektar Therapeutics100
已完成
1 期
A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusNCT03556007Nektar Therapeutics48
已完成
1 期
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy ParticipantsHealthy ParticipantsNCT04882150Bristol-Myers Squibb102
已完成
1 期
A Single and Multiple Ascending Dose Study of ANX009 in Normal Healthy Volunteers (NHV)Safety and Tolerability in Healthy VolunteersNCT04535752Annexon, Inc.48